title: Stability of cefepime in aqueous eye drops.
abstract: The aim of the studies was to determine HPLC the stability of cefepime in 1% and 5% buffered eye drops of developed formulary composition, which were stored for 30 days at the temperature of 4 degrees C and 20 degrees C, protected from light. Separation was performed on RP18 Gemini octadecylsilane column (250 mm x 4.6 mm, 5.0 microm) at a temperature of 25 degrees C. The mobile phase consisted of 0.015 M solution of sodium salt of pentane sulphonic acid brought to pH 4.0 with glacial acetic acid and 45% KOH solution and acetonitrile 94:6 w/w, with detection of 254 nm. The method was linear in the range of 12.6-125 microg/ml (R2 = 0.9996). The limit of detection (LOD) was 3 microg/ml and limit of quantification (LOQ) was 10 microg/ml. 10% degradation of cefepime in 1% and 5% buffered eye drops stored at the temperature of 4 degrees C, depending on the composition of the eye drops, occurred after 21-27 days in 1% eye drops and 18-21 days in 5% eye drops. In the eye drops, which were stored at the temperature of 20 degrees C, 10% degradation of cefepime took place on the third day of storage regardless of formulary composition of 1% and 5% drops. Cefepime stability lasting a couple of weeks in 1% and 5% solution allows extemporaneous preparation of buffered eye drops containing cefepime.
authors.affiliation: Department of Drug Form Technology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Bydgoszcz, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Kodym
authors.forename: M
authors.initials: M
authors.lastname: Pawłowska
authors.forename: J K
authors.initials: JK
authors.lastname: Rumiński
authors.forename: A
authors.initials: A
authors.lastname: Bartosińska
authors.forename: A
authors.initials: A
authors.lastname: Kieliba
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry*; D000077723:Cefepime; D002511:Cephalosporins / Q000008:administration & dosage / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D009883:Ophthalmic Solutions; D009994:Osmolar Concentration; D015203:Reproducibility of Results; D013242:Sterilization; D013696:Temperature; D014783:Viscosity
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D005079:Excipients; D007202:Indicators and Reagents; D009883:Ophthalmic Solutions; D000077723:Cefepime